An interventional study of Deferasirox (DFX) and Deferoxamine (DFO) in Pateints of β-thalassemia Major With Iron Overload, sponsored by RESnTEC, Institute of Research. Completed at 1 site in Pakistan. Open to participants aged 2 Years to 15 Years. Per ClinicalTrials.gov, last updated 2024-06-21.
Sponsored by RESnTEC, Institute of Research · Not applicable, Interventional, and Treatment
This study was planned to compare deferasirox and desferrioxamine in terms of mean serum ferritin levels in patients of β-thalassemia major having Iron overload. Choosing an effective iron chelator is crucial to increasing iron chelation therapy compliance. Not much local data exists in Pakistan comparing the effectiveness of deferasirox (DFX) and desferrioxamine (DFO), so, this study would be helpful in providing baseline data and formulating new protocols for iron chelation therapy, in which DFX may be a useful oral alternative to parenteral DFO.
156 studies on the registry are indexed under Iron Overload; 6 are open to participants now.
This study's enrollment of 142 is above the median of 60 across 97 interventional studies indexed under Iron Overload.
Browse Iron Overload studies →RESnTEC, Institute of Research is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DFX group (n=71) included children who used oral (tablet) DFX at a dose of 30 mg/kg once daily for a duration of 6 months.
Drug: Deferasirox (DFX)
DFO group (n=71) included children who were given DFO at a dose of 50 mg/kg through the subcutaneous route by infusion pump five days a week
Drug: Deferoxamine (DFO)
Oral DFX at a dose of 30mg/kg daily advised for a duration of 6 months.
Also known as: Deferasirox
DFO group (n=71) included children who were given DFO at a dose of 50 mg/kg through the subcutaneous route by infusion pump five days a week for a duration of 6 months.
Also known as: Deferoxamine
Mean Serum Ferritin Levels
Change in mean serum ferritin level from baseline for each group.
Time frame: 6 months
Plan to share: No — Data can be shared with other researchers on a reasonable resquest to parimary researcher.
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Deferasirox · Deferoxamine
RESnTEC, Institute of Research